BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMAGE

    MDR report key: 2210583 · Received August 10, 2011

    Report

    Report Number
    2954746-2011-00012
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    February 7, 2011
    Report Date
    April 25, 2011
    Manufacturer
    SOLTA MED
    Product Code
    GEI
    PMA / PMN Number
    K090580
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT BELIEVES THAT INJURY OCCURRED DURING A LASER-LIPO PROCEDURE PERFORMED THE SAME DAY AND NOT DURING THE THERMAGE PROCEDURE, SO PT DOES NOT BELIEVE THE BURNS SHE RECEIVED WERE FROM THE THERMAGE CPT RETURN PAD. ACCORDING TO THE TREATING SITE, PT WAS UNDER CONSCIOUS SEDATION AND THEY STATE THE BURNS OCCURRED DURING THE THERMAGE PROCEDURE. OF NOTE IS THAT (B)(4) DOES NOT ENDORSE CONSCIOUS SEDATION. PER THE THERMAGE CPT TECHNICAL USER'S MANUAL, "BASED ON CUSTOMER FEEDBACK AND INTERNAL STUDIES, (B)(4) RECOMMENDS THAT PT FEEDBACK REGARDING THEIR PERCEPTION OF HEAT OR DISCOMFORT DURING THE PROCEDURE IS ESSENTIAL INPUT TO GUIDE THE OPERATOR IN DETERMINING SAFE AND EFFECTIVE TREATMENT LEVELS." PER THE THERMAGE TECHNICAL USER MANUAL, "THE RETURN PAD MUST BE KEPT DRY." SITE STATED THAT THE RETURN PAD MAY HAVE GOTTEN WET DURING THE PROCEDURE. (B)(4) RECOMMENDS PLACEMENT OF THE RETURN PAD ON THE UPPER BACK DURING TREATMENT. IN THIS CASE, THE RETURN PAD WAS INAPPROPRIATELY PLACED ON THE UPPER THIGH. THE RETURN PAD IN QUESTION WAS DISCARDED, THUS NOT RETURNED TO (B)(4) FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(4) WAS NOTIFIED OF AN EVENT RELATED TO A THERMAGE TREATMENT PERFORMED ON (B)(6) 2011. ACCORDING TO THE SITE AT WHICH THE TREATMENT WAS PERFORMED, A PT WAS BEING TREATED ON THE ABDOMEN AND RECEIVED TWO BURNS IN THE REGION OF THE RETURN PAD. WHEN FOLLOWING UP WITH THE SITE, ON (B)(6) 2011, (B)(4) WAS INFORMED THAT THE PT WAS HEALING WITHOUT COMPLICATIONS. ON (B)(6) 2011, (B)(6) RECEIVED INFO FROM THE PT INVOLVED IN THE EVENT THAT SHE HAD RESIDUAL SCARRING. REPORTABILITY WAS DETERMINED ON (B)(6) 2011, AFTER CONFIRMING WITH THE SITE THAT THE INJURY WAS MORE SERIOUS THAN PREVIOUSLY BELIEVED. ADDITIONAL INFO PERTINENT TO THE CASE WILL BE PROVIDED IN THE MANUFACTURER NARRATIVE SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMAGE ELECTROSURGICAL UNIT AND ACCESSORIES GEI SOLTA MED TG-2B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other